Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA)

  • STATUS
    Recruiting
  • End date
    Sep 14, 2022
  • participants needed
    330
  • sponsor
    Allergan
Updated on 23 July 2021
Investigator
Clinical Trials Registry Team
Primary Contact
East Carolina University (2.7 mi away) Contact
+40 other location

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.

Details
Condition Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation, Post-Operative Atrial Fibrillation
Treatment Placebo, AGN-151607
Clinical Study IdentifierNCT03779841
SponsorAllergan
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form
Written informed consent from the participant has been obtained prior to any study-related procedures
Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg. Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent (European Union sites)
Participants who are scheduled to undergo open-chest cardiac surgery. Includes: coronary artery bypass graft (CABG) and/or valve repair/replacement
Inclusionary valve repair/replacement procedures for the primary reason for
A male participant must agree to use contraception until Day 60 and refrain from donating sperm during this period
surgery include: Aortic valve repair/replacement, Mitral valve
repair/replacement, Combination of aortic and tricuspid valve
repair/replacement, Combination of mitral and tricuspid valve
repair/replacement CABG/valve combination procedures (when valvular procedure
is one of the 4 sub-bulleted procedures immediately above), Left Atrial
Able, as assessed by the investigator, and willing to follow study instructions and likely to complete required study visit
Appendage (LAA) procedures are allowed if CABG and/or valve repair or
replacement is the qualifying surgical procedure, but is not a qualifying
surgical procedure on its own
A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization) not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP). A WOCBP who agrees to follow the contraceptive guidance until after Day 60
In sinus rhythm for the last 48 hours prior to randomization based on standard-of care assessments and study ECGs (note: continuous ECG monitoring for 48 hours is not required; prior history of paroxysmal AF is acceptable)
Willing to wear an electrocardiogram (ECG) patch for a full 30 days post-surgery and for 7 days after each study visit

Exclusion Criteria

Any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function
Participants with presence or history of any of the following within 3 months prior to the Day 1 visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment: aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or otherwise compromised respiratory function
Permanent/persistent atrial fibrillation (AF)
Has a known allergy or sensitivity to any botulinum toxin type A preparation
Has a known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive; hydrogel-based adhesive)
Left ventricular ejection fraction (LVEF) < 25%
Any uncontrolled clinically significant medical condition other than the one under study that, in the investigator's opinion, would put the participant at an unacceptable risk with exposure to botulinum toxin type A
Exclusionary valve repair/replacement procedures include: Combination of aortic and mitral valve repair/replacement, Isolated tricuspid valve repair/replacement
Class I or III antiarrhythmic drugs unless proper washout was documented
Botulinum toxin type A (of any serotype) use within 6 months of randomization
Has been immunized for any botulinum toxin type A serotype as determined by participant medical history
Preoperative need for inotropes/vasopressors or intra-aortic balloon pump
History of ablation for AF
Severe (> 55 mm left atrial diameter) left atrial enlargement
Planned ablation procedure for AF at the time of surgery
Emergency surgery
Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Presence or history of symptomatic atrioventricular block > 1st degree within the last 30 days (note: presence of a pacemaker is not exclusionary per se)
Females who are pregnant, nursing, or planning a pregnancy during the study
Prior open-chest, sternotomy cardiac surgery
Participants have diagnostic assessments which in the opinion of the investigator prevent participation in the study
Impaired prognosis defined as EuroSCORE II > 7% perioperative mortality at screening is exclusionary
The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
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